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101. Global cardiovascular risk evaluation

Author

Filippi, Alessandro, primary, Giampaoli, Simona, additional, Lapi, Francesco, additional, Mazzaglia, Giampiero, additional, Palmieri, Luigi, additional, Pecchioli, Serena, additional, Brignoli, Ovidio, additional, Cricelli, Claudio, additional, Simonetti, Monica, additional, Sessa, Emiliano, additional, and Marchioli, Roberto, additional

Published
2016
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102. Prescribing pattern of antipsychotic drugs during the years 1996-2010: a population-based database study in Europe with a focus on torsadogenic drugs

Author

Oteri, Alessandro, primary, Mazzaglia, Giampiero, additional, Pecchioli, Serena, additional, Molokhia, Mariam, additional, Ulrichsen, Sinna Pilgaard, additional, Pedersen, Lars, additional, Poluzzi, Elisabetta, additional, De Ponti, Fabrizio, additional, Garbe, Edeltraut, additional, Schink, Tania, additional, Herings, Ron, additional, Bezemer, Irene D., additional, Sturkenboom, Miriam C. J. M., additional, and Trifirò, Gianluca, additional

Published
2016
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104. Predictive validity of measures of comorbidity in older community dwellers: the insufficienza cardiaca negli anziani residenti a dicomano study

Author

Bari, Mauro Di, Virgillo, Andriana, Matteuzzi, Daniela, Inzitari, Marco, Mazzaglia, Giampiero, Pozzi, Claudia, Geppetii, Pierangelo, Masotti, Giulio, Marchionni, Niccolo, and Pini, Riccardo

Subjects
Aged -- Health aspects, Comorbidity -- Analysis, Health, Seniors
Abstract

A study to compare the predictive validity of disease count, Charlson Comorbidity Index, Index of Co-Existent Diseases, Geriatric Index of Comorbidity and Chronic Diseases Score, in unselected community-dwelling elderly populations, is presented.

Published
2006

105. Oral bisphosphonates do not increase the risk of severe upper gastrointestinal complications: a nested case–control study

Author

Ghirardi, Arianna, Scotti, Lorenza, Vedova, Gianluca D., D'Oro, Luca C., Lapi, Francesco, Cipriani, Francesco, Caputi, Achille P., Vaccheri, Alberto, Gregori, Dario, Gesuita, Rosaria, Vestri, Annarita, Staniscia, Tommaso, Mazzaglia, Giampiero, Corrao, Giovanni, Sessa, E., Arcoraci, V., Parodi, A., Zambon, A., Montanaro, N., Piccinni, C., Suzzi, C., Puccini, A., Sturkenboom, M., Geppetti, P., Sati, L., Di Bari, M., Forlan, F., Carle, F., Menna, A., Valenti, M., Ghirardi A, Scotti L, Vedova GD, D'Oro LC, Lapi F, Cipriani F, Caputi AP, Vaccheri A, Gregori D, Gesuita R, Vestri A, Staniscia T, Mazzaglia G, Corrao G, AIFA-BEST Investigators, Ghirardi, A, Scotti, L, DELLA VEDOVA, G, D'Oro, L, Lapi, F, Cipriani, F, Caputi, A, Vaccheri, A, Gregori, D, Gesuita, R, Vestri, A, Staniscia, T, Mazzaglia, G, Corrao, G, AIFA BEST, I, and Medical Informatics

Subjects
Male, Gastrointestinal Diseases, Administration, Oral, Comorbidity, Risk Factors, 80 and over, Secondary Prevention, Drug safety, Aged, 80 and over, Bone Density Conservation Agents, Diphosphonates, Incidence, Incidence (epidemiology), Gastroenterology, Bisphosphonates, General Medicine, Middle Aged, Calcium Channel Blockers, Italy, Administration, Cohort, Upper gastrointestinal complications, Nested case-control, Female, Research Article, Oral, Healthcare utilization database, medicine.medical_specialty, Database, Fracture prevention, Internal medicine, medicine, Humans, Bisphosphonate, MED/01 - STATISTICA MEDICA, Aged, business.industry, Case-control study, Case-Control Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Osteoporotic Fractures, Odds ratio, medicine.disease, Confidence interval, Surgery, Regimen, Nested case-control study, Bisphosphonates, Drug safety, Healthcare utilization database, Upper gastrointestinal complications, Osteoporosis, healthcare utilization database, upper gastrointestinal complications, drug safety, bisphosphonates, business
Abstract

Background Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures. Methods A nested case–control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates. Results Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities. Conclusions Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.

Published
2014
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106. The EU-ADR alliance: A federated collaborative framework for drug safety studies

Author

Molero, Eva, Diaz, Carlos, Ferran Sanz, Oliveira, Jose Luis, Trifiro, Gianluca, Fourrier-Reglat, Annie, Molokhia, Mariam, Pedersen, Lars, Boyer, Scott, Scotti, Lorenza, Gini, Rosa, Herings, Ron, Giaquinto, Carlo, Isabel Loza, Maria, Mazzaglia, Giampiero, Lei, Johan, Sturkenboom, Miriam, Molero, E, Diaz, C, Sanz, F, Oliveira, J, Trifiro, G, Fourrier-Reglat, A, Molokhia, M, Pedersen, L, Boyer, S, Scotti, L, Gini, R, Herings, R, Giaquinto, C, Loza, M, Mazzaglia, G, van der Lei, J, and Sturkenboom, M

Subjects
Spontaneuous reporting, Electronic Healthcare Database, Adverse Drug Reaction, Signal detection
Abstract

Background: EU-ADR is a European research project resulting in a computerized system exploiting data from electronic healthcare records (EHR) for early detection of adverse drug reactions. The system identifies drug-event associations from epidemiological data and uses computational and text mining techniques to substantiate them in the light of current biomedical knowledge. EHRs of +30 million patients from several European countries are available. The EU-ADR system has been initially built for addressing relevant events for drug safety surveillance such as upper gastrointestinal bleeding, anaphylactic shock, acute renal failure, rhabdomyolysis, myocardial infarction, etc. Objectives: Based on the resulting system, the EU-ADR Alliance is devised as a collaboration framework for running studies and answering drug safety questions in a federated manner, using extracted data from multiple European private and public EHR databases. Methods: The EU-ADR Alliance will be composed by members bringing in relevant expertise (EHR databases, information technologies). It is based on the concept of federated databases, non-competition with its members, independence and scientific interest. It will undertake commissioned or members individual studies and the annual Alliance Research Plan. The advantage of running studies through the Alliance is that more powerful studies can be set up and run faster, given that a governance structure and working methods are in place. Results: EU-ADR Alliance candidate member organisations include eight European EHR database with access to +45 million patients from Italy, Netherlands, UK, Germany and Denmark. A proof of concept phase is ongoing. Studies contracted by the European Medicines Agency will utilise the EU-ADR Alliance concept and operations. These studies concern the patterns of use of oral contraceptives; exploring an association between cardiac valve disorders and the use of biphosphonates and the monitoring of the effectiveness of risk minimisation in patients treated with pioglitazone-containing products Conclusions: The EU-ADR Alliance will provide an unprededented framework to run drug safety studies across EHR databases with important power and speed benefits.

Published
2012
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107. Trends in cardiovascular diseases burden and vascular risk factors in Italy: The Global Burden of Disease study 1990–2017

Author

Cortesi, Paolo A, Fornari, Carla, Madotto, Fabiana, Conti, Sara, Naghavi, Mohsen, Bikbov, Boris, Briant, Paul S, Caso, Valeria, Crotti, Giacomo, Johnson, Catherine, Nguyen, Minh, Palmieri, Luigi, Perico, Norberto, Profili, Francesco, Remuzzi, Giuseppe, Roth, Gregory A, Traini, Eugenio, Voller, Fabio, Yadgir, Simon, Mazzaglia, Giampiero, Monasta, Lorenzo, Giampaoli, Simona, and Mantovani, Lorenzo G

Abstract

Aims An exhaustive and updated estimation of cardiovascular disease burden and vascular risk factors is still lacking in European countries. This study aims to fill this gap assessing the global Italian cardiovascular disease burden and its changes from 1990 to 2017 and comparing the Italian situation with European countries.Methods All accessible data sources from the 2017 Global Burden of Disease study were used to estimate the cardiovascular disease prevalence, mortality and disability-adjusted life years and cardiovascular disease attributable risk factors burden in Italy from 1990 to 2017. Furthermore, we compared the cardiovascular disease burden within the 28 European Union countries.Results Since 1990, we observed a significant decrease of cardiovascular disease burden, particularly in the age-standardised prevalence (–12.7%), mortality rate (–53.8%), and disability-adjusted life years rate (–55.5%). Similar improvements were observed in the majority of European countries. However, we found an increase in all-ages prevalence of cardiovascular diseases from 5.75 m to 7.49 m Italian residents. Cardiovascular diseases still remain the first cause of death (34.8% of total mortality). More than 80% of the cardiovascular disease burden could be attributed to known modifiable risk factors such as high systolic blood pressure, dietary risks, high low density lipoprotein cholesterol, and impaired kidney function.Conclusions Our study shows a decline in cardiovascular mortality and disability-adjusted life years, which reflects the success in reducing disability, premature death and early incidence of cardiovascular diseases. However, the burden of cardiovascular diseases is still high. An approach that includes the cooperation and coordination of all stakeholders of the Italian National Health System is required to further reduce this burden.

Published
2024
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108. EU-ADR healthcare database network vs. spontaneous reporting system database:preliminary comparison of signal detection

Author

Trifirò, Gianluca, Patadia, Vaishali, Schuemie, Martijn J, Coloma, Preciosa M, Gini, Rosa, Herings, Ron, Hippisley-Cox, Julia, Mazzaglia, Giampiero, Giaquinto, Carlo, Scotti, Lorenza, Pedersen, Lars, Avillach, Paul, Sturkenboom, Miriam C J M, van der Lei, Johan, and Eu-Adr Group

Subjects
Europe, Databases, Factual, Medical Records Systems, Computerized, Drug Toxicity, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Data Mining, Humans, World Health Organization, United States
Abstract

The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases. EU-ADR data sources consist of eight databases in four countries (Denmark, Italy, Netherlands, and United Kingdom) that are virtually linked through distributed data network. A custom-built software (Jerboa©) elaborates harmonized input data that are produced locally and generates aggregated data which are then stored in a central repository. Those data are subsequently analyzed through different statistics (i.e. Longitudinal Gamma Poisson Shrinker). As potential signals, all the drugs that are associated to six events of interest (bullous eruptions - BE, acute renal failure - ARF, acute myocardial infarction - AMI, anaphylactic shock - AS, rhabdomyolysis - RHABD, and upper gastrointestinal bleeding - UGIB) have been detected via different data mining techniques in the two systems. Subsequently a comparison concerning the number of drugs that could be investigated and the potential signals detected for each event in the spontaneous reporting systems (SRSs) and EU-ADR network was made. SRSs could explore, as potential signals, a larger number of drugs for the six events, in comparison to EU-ADR (range: 630-3,393 vs. 87-856), particularly for those events commonly thought to be potentially drug-induced (i.e. BE: 3,393 vs. 228). The highest proportion of signals detected in SRSs was found for BE, ARF and AS, while for ARF, and UGIB in EU-ADR. In conclusion, it seems that EU-ADR longitudinal database network may complement traditional spontaneous reporting system for signal detection, especially for those adverse events that are frequent in general population and are not commonly thought to be drug-induced. The methodology for signal detection in EU-ADR is still under development and testing phase.

Published
2011

109. Sindrome di guillain-barré e vaccinazione antinfluenzale

Author

Galeotti, F, Massari, M, D’Alessandro, R, Beghi, B, Benedetti, M, Chiò, A, Filippini, G, Logroscino G, MAZZAGLIA, GIAMPIERO, Pugliatti, M, Santuccio, C, Trotta, F, Tartaglia, L, Raschetti, R, Galeotti, F, Massari, M, D’Alessandro, R, Beghi, B, Benedetti, M, Chiò, A, Filippini, G, Logroscino, G, Mazzaglia, G, Pugliatti, M, Santuccio, C, Trotta, F, Tartaglia, L, and Raschetti, R

Subjects
sindrome di guillain-barré, vaccini, epidemiologia, influenza, incidenza
Published
2011

110. Drug-Related Upper Gastrointestinal Bleeding: Comparison of Signal Detection Results between Spontaneous Reporting and Longitudinal Healthcare Databases

Author

Patadia, Vaishali, Rosa Gini, Herings, Ron, Mazzaglia, Giampiero, Picelli, Gino, Scotti, Lorenza, Pedersen, Lars, Lei, Johan, Sturkenboom, Miriam, Trifiro, Gianluca, Patadia, V, Gini, R, Herings, R, Mazzaglia, G, Picelli, G, Scotti, L, Pedersen, L, van der Lei, J, Sturkenboom, M, and Trifiro, G

Subjects
safety, validation, adverse drug-reaction, project, experience, pharmacovigilance, design, gastrintestinal event, database, performance
Published
2010

111. Psychotropic Drug Use in the Elderly Across Europe: A Perspective from the EU-ADR Project

Author

Coloma, Preciosa, Trifiro, Gianluca, Schuemie, Martijn, Rosa Gini, Herings, Ron, Hippisley-Cox, Julia, Mazzaglia, Giampiero, Corrao, Giovanni, Pedersen, Lars, Lei, Johan, Sturkenboom, Miriam, Coloma, P, Trifiro', G, Schuemie, M, Gini, R, Herings, R, Hippisley-Cox, J, Mazzaglia, G, Corrao, G, Pedersen, L, van der Lei, J, and Sturkenboom, M

Subjects
Drug Utilization, Elderly, Database, Psychotropic Drug
Published
2010

112. Design and evaluation of a semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European EU-ADR project

Author

Avillach, Paul, Joubert, Michel, Thiessard, Frantz, Trifirò, Gianluca, Dufour, Jean-Charles, Pariente, Antoine, Mougin, Fleur, Polimeni, Giovanni, Catania Maria Antonietta, Giaquinto, Carlo, Mazzaglia, Giampiero, Fornari, Carla, Herings, Ron, Gini, Rosa, Hippisley-Cox, Julia, Molokhia, Mariam, Pedersen, Lars, Fourrier-Réglat, Annie, Sturkenboom, Miriam, Fieschi, Marius, Safran, C, Reti, S, Marin, HF, Avillach, P, Joubert, M, Thiessard, F, Trifirò, G, Dufour, J, Pariente, A, Mougin, F, Polimeni, G, Catania, M, Giaquinto, C, Mazzaglia, G, Fornari, C, Herings, R, Gini, R, Hippisley-Cox, J, Molokhia, M, Pedersen, L, Fourrier-Réglat, A, Sturkenboom, M, and Fieschi, M

Subjects
Databases, Databases, Factual, Terminology as Topic, Humans, Medical Records, Unified Medical Language System, Electronic Health Records, Semantics, Medical Record, Electronic Health Record, Factual, Human
Abstract

The overall objective of the EU-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight different databases, containing health records of more than 30 million European citizens, are involved in the project. Unique queries cannot be performed across different databases because of their heterogeneity: Medical record and Claims databases, four different terminologies for coding diagnoses, and two languages for the information described in free text. The aim of our study was to provide database owners with a common basis for the construction of their queries. Using the UMLS, we provided a list of medical concepts, with their corresponding terms and codes in the four terminologies, which should be considered to retrieve the relevant information for the events of interest from the databases.

Published
2010

113. Using real-world healthcare data for pharmacovigilance signal detection – the experience of the EU-ADR project

Author

Patadia, Vaishali K, primary, Coloma, Preciosa, additional, Schuemie, Martijn J, additional, Herings, Ron, additional, Gini, Rosa, additional, Mazzaglia, Giampiero, additional, Picelli, Gino, additional, Fornari, Carla, additional, Pedersen, Lars, additional, van der Lei, Johan, additional, Sturkenboom, Miriam, additional, and Trifirò, Gianluca, additional

Published
2014
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114. Effects of a computerized decision support system in improving pharmacological management in high-risk cardiovascular patients: A cluster-randomized open-label controlled trial

Author

Mazzaglia, Giampiero, primary, Piccinni, Carlo, additional, Filippi, Alessandro, additional, Sini, Giovanna, additional, Lapi, Francesco, additional, Sessa, Emiliano, additional, Cricelli, Iacopo, additional, Cutroneo, Paola, additional, Trifirò, Gianluca, additional, Cricelli, Claudio, additional, and Caputi, Achille Patrizio, additional

Published
2014
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115. Systemic antibiotic prescribing to paediatric outpatients in 5 European countries: a population-based cohort study

Author

Holstiege, Jakob, primary, Schink, Tania, additional, Molokhia, Mariam, additional, Mazzaglia, Giampiero, additional, Innocenti, Francesco, additional, Oteri, Alessandro, additional, Bezemer, Irene, additional, Poluzzi, Elisabetta, additional, Puccini, Aurora, additional, Ulrichsen, Sinna Pilgaard, additional, Sturkenboom, Miriam C, additional, Trifirò, Gianluca, additional, and Garbe, Edeltraut, additional

Published
2014
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117. Chronic disease prevalence from Italian administrative databases in the VALORE project: a validation through comparison of population estimates with general practice databases and national survey

Author

Gini, Rosa, Francesconi, Paolo, Mazzaglia, Giampiero, Cricelli, Iacopo, Pasqua, Alessandro, Gallina, Pietro, Brugaletta, Salvatore, Donato, Daniele, Donatini, Andrea, Marini, Alessandro, Zocchetti, Carlo, Cricelli, Claudio, Damiani, Gianfranco, Bellentani, Maria Donata, Sturkenboom, Miriam Cjn, Schuemie, Martijn J., Damiani, Gianfranco (ORCID:0000-0003-3028-6188), Gini, Rosa, Francesconi, Paolo, Mazzaglia, Giampiero, Cricelli, Iacopo, Pasqua, Alessandro, Gallina, Pietro, Brugaletta, Salvatore, Donato, Daniele, Donatini, Andrea, Marini, Alessandro, Zocchetti, Carlo, Cricelli, Claudio, Damiani, Gianfranco, Bellentani, Maria Donata, Sturkenboom, Miriam Cjn, Schuemie, Martijn J., and Damiani, Gianfranco (ORCID:0000-0003-3028-6188)

Abstract

BACKGROUND: Administrative databases are widely available and have been extensively used to provide estimates of chronic disease prevalence for the purpose of surveillance of both geographical and temporal trends. There are, however, other sources of data available, such as medical records from primary care and national surveys. In this paper we compare disease prevalence estimates obtained from these three different data sources. METHODS: Data from general practitioners (GP) and administrative transactions for health services were collected from five Italian regions (Veneto, Emilia Romagna, Tuscany, Marche and Sicily) belonging to all the three macroareas of the country (North, Center, South). Crude prevalence estimates were calculated by data source and region for diabetes, ischaemic heart disease, heart failure and chronic obstructive pulmonary disease (COPD). For diabetes and COPD, prevalence estimates were also obtained from a national health survey. When necessary, estimates were adjusted for completeness of data ascertainment. RESULTS: Crude prevalence estimates of diabetes in administrative databases (range: from 4.8% to 7.1%) were lower than corresponding GP (6.2%-8.5%) and survey-based estimates (5.1%-7.5%). Geographical trends were similar in the three sources and estimates based on treatment were the same, while estimates adjusted for completeness of ascertainment (6.1%-8.8%) were slightly higher. For ischaemic heart disease administrative and GP data sources were fairly consistent, with prevalence ranging from 3.7% to 4.7% and from 3.3% to 4.9%, respectively. In the case of heart failure administrative estimates were consistently higher than GPs' estimates in all five regions, the highest difference being 1.4% vs 1.1%. For COPD the estimates from administrative data, ranging from 3.1% to 5.2%, fell into the confidence interval of the Survey estimates in four regions, but failed to detect the higher prevalence in the most Southern region (4.0% in adminis

Published
2013

118. A national survey of the management of atrial fibrillation with antithrombotic drugs in Italian primary care

Author

Mazzaglia, G, Filippi, A, Alacqua, M, Cowell, W, Shakespeare, A, Mantovani, L, Bianchi, C, Cricelli, C, Mazzaglia, Giampiero, Filippi, Alessandro, Alacqua, Marianna, Cowell, Warren, Shakespeare, Annabelle, Mantovani, Lorenzo G., Bianchi, Cosetta, Cricelli, Claudio, Mazzaglia, G, Filippi, A, Alacqua, M, Cowell, W, Shakespeare, A, Mantovani, L, Bianchi, C, Cricelli, C, Mazzaglia, Giampiero, Filippi, Alessandro, Alacqua, Marianna, Cowell, Warren, Shakespeare, Annabelle, Mantovani, Lorenzo G., Bianchi, Cosetta, and Cricelli, Claudio

Abstract

The aims of this study were to investigate trends in the incidence of diagnosed atrial fibrillation (AF), and to identify factors associated with the prescription of antithrombotics (ATs) and to identify the persistence of patients with oral anticoagulant (OAC) treatment in primary care. Data were obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database from 2001 to 2004. The age-standardised incidence of AF was: 3.9-3.0 cases, and 3.6-3.0 cases per 1,000 person-years in males and females, respectively. During the study period, 2,016 (37.2%) patients had no prescription, 1,663 (30.7%) were prescribed an antiplatelet (AP) agent, 1,440 (26.6%) were prescribed an OAC and 301 (5.5%) had both prescriptions. The date of diagnosis (p = 0.0001) affected the likelihood of receiving an OAC. AP, but not OAC, use significantly increased with a worsening stroke risk profile using the CHADS2 risk score. Older age increased the probability (p < 0.0001) of receiving an AP, but not an OAC. Approximately 42% and 24% of patients persisted with OAC treatment at one and two years, respectively, the remainder interrupted or discontinued their treatment. Underuse and discontinuation of OAC treatment is common in incident AF patients. Risk stratification only partially influences AT management

Published
2010

120. 812 Synergistic Effects of Concomitant Use of Non-Selective NSAIDs, Coxibs and Low-Dose Aspirin on Risk of Upper Gastrointestinal Bleeding

Author

Masclee, Gwen, primary, Valkhoff, Vera E., additional, Coloma, Preciosa M., additional, de Ridder, Maria, additional, Schuemie, Martijn, additional, Herings, Ron M., additional, Gini, Rosa, additional, Mazzaglia, Giampiero, additional, Picelli, Gino, additional, Scotti, Lorenza, additional, Pedersen, Lars, additional, Kuipers, Ernst J., additional, van der Lei, Johan, additional, and Sturkenboom, Miriam C., additional

Published
2013
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121. 1038 Cyclo-Oxygenase-2 Inhibitors or Nonselective NSAIDs Plus Gastroprotective Agents: What to Prescribe in Daily Clinical Practice?

Author

Masclee, Gwen, primary, Valkhoff, Vera E., additional, van Soest, Eva M., additional, Schade, Rene, additional, Mazzaglia, Giampiero, additional, Molokhia, Mariam, additional, Trifiro, Gianluca, additional, Goldstein, Jay L., additional, Hernandez-Diaz, Sonia, additional, Kuipers, Ernst J., additional, and Sturkenboom, Miriam C., additional

Published
2013
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122. Effects of a computerized decision support system in improving pharmacological management in high-risk cardiovascular patients: A cluster-randomized open-label controlled trial.

Author

Mazzaglia, Giampiero, Piccinni, Carlo, Filippi, Alessandro, Sini, Giovanna, Lapi, Francesco, Sessa, Emiliano, Cricelli, Iacopo, Cutroneo, Paola, Trifirò, Gianluca, Cricelli, Claudio, and Caputi, Achille Patrizio

Subjects
*DECISION support systems, *CARDIOVASCULAR agents, *CARDIOVASCULAR diseases risk factors, *CHI-squared test, *CLUSTER analysis (Statistics), *CONFIDENCE intervals, *DRUG interactions, *DRUG prescribing, *INFORMATION storage & retrieval systems, *MEDICAL databases, *MEDICAL cooperation, *MEDICAL protocols, *MYOCARDIAL infarction, *TYPE 2 diabetes, *GENERAL practitioners, *PROBABILITY theory, *REGRESSION analysis, *RESEARCH, *RESEARCH funding, *STATISTICAL hypothesis testing, *STROKE, *T-test (Statistics), *PHYSICIAN practice patterns, *RANDOMIZED controlled trials, *POLYPHARMACY, *DATA analysis software, *DESCRIPTIVE statistics, *ODDS ratio
Abstract

This study was aimed to investigate the effects of computerized decision support system in improving the prescription of drugs for cardiovascular prevention. A total of 197 Italian general practitioners were randomly allocated to receive either the alerting computerized decision support system integrated into standard software (intervention arm) or the standard software alone (control arm). Data on 21230 patients with diabetes, 3956 with acute myocardial infarction, and 2158 with stroke were analysed. The proportion of patients prescribed with cardiovascular drugs and days of drug–drug interaction exposure were evaluated. Computerized decision support system significantly increased the proportion of patients with diabetes prescribed with antiplatelet drugs (intervention: +2.7% vs. control: +0.15%; p < 0.001) or lipidlowering drugs (+4.2% vs. +2.8%; p = 0.001). A statistically significant decrease in days of potential interactions has been observed only among patients with stroke (−1.2 vs. −0.5 days/person-year; p = 0.001). In conclusion, computerized decision support system significantly increased the use of recommended cardiovascular drugs in diabetic patients, but it did not influence the exposure to potential interactions [ABSTRACT FROM AUTHOR]

Published
2016
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123. Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project

Author

Avillach, Paul, primary, Coloma, Preciosa M, additional, Gini, Rosa, additional, Schuemie, Martijn, additional, Mougin, Fleur, additional, Dufour, Jean-Charles, additional, Mazzaglia, Giampiero, additional, Giaquinto, Carlo, additional, Fornari, Carla, additional, Herings, Ron, additional, Molokhia, Mariam, additional, Pedersen, Lars, additional, Fourrier-Réglat, Annie, additional, Fieschi, Marius, additional, Sturkenboom, Miriam, additional, van der Lei, Johan, additional, Pariente, Antoine, additional, and Trifirò, Gianluca, additional

Published
2012
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124. Epidemiology of gout and hyperuricaemia in Italy during the years 2005–2009: a nationwide population-based study

Author

Trifirò, Gianluca, primary, Morabito, Paolo, additional, Cavagna, Lorenzo, additional, Ferrajolo, Carmen, additional, Pecchioli, Serena, additional, Simonetti, Monica, additional, Bianchini, Elisa, additional, Medea, Gerardo, additional, Cricelli, Claudio, additional, Caputi, Achille P, additional, and Mazzaglia, Giampiero, additional

Published
2012
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128. Suboptimal Gastroprotective Coverage of NSAID Use and the Risk of Upper Gastrointestinal Complications

Author

van Soest, Eva M., primary, Valkhoff, Vera E., additional, Mazzaglia, Giampiero, additional, Schade, Rene, additional, Molokhia, Mariam, additional, Goldstein, Jay L., additional, Hernandez-Diaz, Sonia, additional, Trifiro, Gianluca, additional, Dieleman, Jeanne, additional, Kuipers, Ernst J., additional, and Sturkenboom, Miriam C., additional

Published
2011
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129. Adherence to Gastroprotective Agents and the Risk of Upper Gastrointestinal Complications in Coxib Users

Author

Valkhoff, Vera E., primary, van Soest, Eva M., additional, Mazzaglia, Giampiero, additional, Schade, Rene, additional, Molokhia, Mariam, additional, Goldstein, Jay L., additional, Hernandez-Diaz, Sonia, additional, Trifiro, Gianluca, additional, Dieleman, Jeanne, additional, Kuipers, Ernst J., additional, and Sturkenboom, Miriam C., additional

Published
2011
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132. Prescribing pattern of antipsychotic drugs in the Italian general population 2000–2005: a focus on elderly with dementia

Author

Trifirò, Gianluca, primary, Sini, Giovanna, additional, Sturkenboom, Miriam C.J.M., additional, Vanacore, Nicola, additional, Mazzaglia, Giampiero, additional, Caputi, Achille P., additional, Cricelli, Claudio, additional, Brignoli, Ovidio, additional, Aguglia, Eugenio, additional, Biggio, Giovanni, additional, and Samani, Fabio, additional

Published
2010
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135. Adherence to Antihypertensive Medications and Cardiovascular Morbidity Among Newly Diagnosed Hypertensive Patients

Author

Mazzaglia, Giampiero, primary, Ambrosioni, Ettore, additional, Alacqua, Marianna, additional, Filippi, Alessandro, additional, Sessa, Emiliano, additional, Immordino, Vincenzo, additional, Borghi, Claudio, additional, Brignoli, Ovidio, additional, Caputi, Achille P., additional, Cricelli, Claudio, additional, and Mantovani, Lorenzo G., additional

Published
2009
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140. The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.

Author

Bie, Sandra, Coloma, Preciosa M., Ferrajolo, Carmen, Verhamme, Katia M. C., Trifirò, Gianluca, Schuemie, Martijn J., Straus, Sabine M. J. M., Gini, Rosa, Herings, Ron, Mazzaglia, Giampiero, Picelli, Gino, Ghirardi, Arianna, Pedersen, Lars, Stricker, Bruno H. C., Lei, Johan, and Sturkenboom, Miriam C. J. M.

Subjects
ELECTRONIC health records, MEDICATION safety, RETROSPECTIVE studies, RELATIVE medical risk, ADVERSE health care events
Abstract

Aim Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years). Methods Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events. Results The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock. Conclusion Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance. [ABSTRACT FROM AUTHOR]

Published
2015
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146. Use of azithromycin and risk of ventricular arrhythmia

Author

Trifirò, Gianluca, de Ridder, Maria, Sultana, Janet, Oteri, Alessandro, Rijnbeek, Peter, Pecchioli, Serena, Mazzaglia, Giampiero, Bezemer, Irene, Garbe, Edeltraut, Schink, Tania, Poluzzi, Elisabetta, Frøslev, Trine, Molokhia, Mariam, Diemberger, Igor, and Sturkenboom, Miriam C.J.M.

Abstract

BACKGROUND:There are conflicting findings from observational studies of the arrhythrogenic potential of azithromycin. Our aim was to quantify the association between azithromycin use and the risk of ventricular arrhythmia.METHODS:We conducted a nested case–control study within a cohort of new antibiotic users identified from a network of 7 population-based health care databases in Denmark, Germany, Italy, the Netherlands and the United Kingdom for the period 1997–2010. Up to 100 controls per case were selected and matched by age, sex and database. Recency of antibiotic use and type of drug (azithromycin was the exposure of interest) at the index date (occurrence of ventricular arrhythmia) were identified. We estimated the odds of ventricular arrhythmia associated with current azithromycin use relative to current amoxicillin use or nonuse of antibiotics (≥ 365 d without antibiotic exposure) using conditional logistic regression, adjusting for confounders.RESULTS:We identified 14 040 688 new antibiotic users who met the inclusion criteria. Ventricular arrhythmia developed in 12 874, of whom 30 were current azithromycin users. The mean age of the cases and controls was 63 years, and two-thirds were male. In the pooled data analyses across databases, azithromycin use was associated with an increased risk of ventricular arrhythmia relative to nonuse of antibiotics (adjusted odds ratio [OR] 1.97, 95% confidence interval [CI] 1.35–2.86). This increased risk disappeared when current amoxicillin use was the comparator (adjusted OR 0.90, 95% CI 0.48–1.71). Database-specific estimates and meta-analysis confirmed results from the pooled data analysis.INTERPRETATION:Current azithromycin use was associated with an increased risk of ventricular arrhythmia when compared with nonuse of antibiotics, but not when compared with current amoxicillin use. The decreased risk with an active comparator suggests significant confounding by indication.

Published
2017
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147. Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures.

Author

Ghirardi, Arianna, Di Bari, Mauro, Zambon, Antonella, Scotti, Lorenza, Della Vedova, Gianluca, Lapi, Francesco, Cipriani, Francesco, Caputi, Achille, Vaccheri, Alberto, Gregori, Dario, Gesuita, Rosaria, Vestri, Annarita, Staniscia, Tommaso, Mazzaglia, Giampiero, and Corrao, Giovanni

Subjects
BONE fracture prevention, CHI-squared test, CONFIDENCE intervals, DIPHOSPHONATES, OSTEOPOROSIS, RESEARCH funding, STATISTICAL sampling, STATISTICAL hypothesis testing, CASE-control method, DATA analysis software, DESCRIPTIVE statistics, ODDS ratio, DISEASE complications
Abstract

Purpose: Osteoporosis is a chronic disease of the bone, whose incidence increases progressively with aging. The main consequences of osteoporosis are fragility fractures, which have considerable medical, social, and economic implications. Adequate treatment of osteoporosis must be considered as a compelling public health intervention. Bisphosphonates (BPs) represent the most significant advance in this field in the past decade, and they are widely used in the treatment of osteoporosis. However, evidence for their effectiveness is limited to secondary prevention, whereas their effect in primary prevention is uncertain and needs further investigation. Methods: Using administrative data collected in the 'Biphosphonates Efficacy-Safety Tradeoff' (BEST) study, a nested case-control study was conducted by including 56,058 participants, aged 55 years who were started on oral BPs from 2003 to 2005. Cases were the 1,710 participants who were hospitalized for osteoporotic fractures until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio of fracture associated with categories of treatment duration. Results: Compared with participants assuming BPs for less than 1 year, those who remained on therapy for at least 2 years had a 21 % (95 % confidence interval (CI) 7 to 33 %) fracture risk reduction. Conclusion: This study provides evidence that BPs, dispensed for primary prevention of osteoporotic fractures, are associated with a reduced risk of osteoporotic fractures after at least 2 years of treatment. [ABSTRACT FROM AUTHOR]

Published
2014
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150. Signal Detection of Potentially Drug-Induced Acute Liver Injury in Children Using a Multi-Country Healthcare Database Network.

Author

Ferrajolo, Carmen, Coloma, Preciosa, Verhamme, Katia, Schuemie, Martijn, Bie, Sandra, Gini, Rosa, Herings, Ron, Mazzaglia, Giampiero, Picelli, Gino, Giaquinto, Carlo, Scotti, Lorenza, Avillach, Paul, Pedersen, Lars, Rossi, Francesco, Capuano, Annalisa, Lei, Johan, Trifiró, Gianluca, and Sturkenboom, Miriam

Subjects
LIVER injuries, DRUG side effects, DATA mining, ELECTRONIC health records, PEDIATRIC research
Abstract

Background: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children. Objectives: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) in children and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations. Methods: We identified potential cases of ALI during exposure to any prescribed/dispensed drug for individuals <18 years old from the EU-ADR network, which includes seven databases from three countries, covering the years 1996-2010. Several new methods for signal detection were applied to identify all statistically significant associations between drugs and ALI. A drug was considered statistically significantly associated with ALI, using all other time as a reference category, if the 95 % CI lower band of the relative risk was >1 and in the presence of at least three exposed cases of ALI. Potentially new signals were distinguished from already known associations concerning ALI (whether in adults and/or in the paediatric population) through manual review of published literature and drug product labels. Results: The study population comprised 4,838,146 individuals aged <18 years, who contributed an overall 25,575,132 person-years of follow-up. Within this population, we identified 1,015 potential cases of ALI. Overall, 20 positive drug-ALI associations were detected. The associations between ALI and domperidone, flunisolide and human insulin were considered as potentially new signals. Citalopram and cetirizine have been previously described as hepatotoxic in adults but not in children, while all remaining associations were already known in both adults and children. Conclusions: Data mining of multiple EHR databases for signal detection confirmed known associations between ALI and several drugs, and identified some potentially new signals in children that require further investigation through formal epidemiologic studies. This study shows that EHRs may complement traditional spontaneous reporting systems for signal detection and strengthening. [ABSTRACT FROM AUTHOR]

Published
2014
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